Status:
COMPLETED
Evaluate Effect of Optison on Pulmonary Artery Systolic Pressure (PASP) and Pulmonary Vascular Resistance (PVR).
Lead Sponsor:
GE Healthcare
Collaborating Sponsors:
ICON Clinical Research
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The design of this study is to conduct a comprehensive safety evaluation of the pulmonary hemodynamic effects of Optison. The study is being conducted in subjects referred for cardiac catheterization ...
Eligibility Criteria
Inclusion
- Must be already scheduled for left and/or right heart catheterization for clinical reasons.
- Must be in sinus rhythm, without an arrhythmia likely to affect the ability to assess pulmonary hemodynamics by catheterization, as determined by the investigator.
- Women of childbearing potential must be using adequate birth control and have a negative pregnancy test.
Exclusion
- History of right-to-left, bi-directional, or transient right-to-left cardiac shunts or diagnosed by color flow Doppler echocardiography during screening.
- Hypersensitivity to Optison, perflutren, blood, blood products, or albumin.
- Female subjects who are nursing mothers.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00878878
Start Date
March 1 2009
End Date
July 1 2010
Last Update
August 24 2012
Active Locations (1)
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1
ICON Development Solutions
Elliott, Maryland, United States, 21043